Medtronic Extended MMT-431AHRecalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 05705244023161), received between Apr 20, 2023 and Sep 25, 2026 — classified as 6 injuries, 168 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (85 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Use of Incorrect Control/Treatment Settings

  It was reported that the patient had experienced infusion set came off due to accidentally pulled out while changing clothes on(b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50894726 ↗
• MalfunctionAug 26, 2026Complete Blockage

  It was reported that patient faced Insulin Flow Blocked event on (b)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50449131 ↗
• MalfunctionAug 6, 2026Partial Blockage

  Patient problems: Hyperglycemia

  MAUDE report 50152905 ↗
• MalfunctionAug 4, 2026Leak/Splash

  It was reported that the patient faced an event where leakage was at the site on (b)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50126068 ↗
• MalfunctionApr 20, 2026Complete Blockage

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INSULIN FLOW BLOCKED ALARM DUE TO OCCLUSION EVENT ON (B)(6) 2026, WHERE INSULIN DOES NOT EXIT THE TUBING THROUGH PLUNGER PUSH. THE BLOCKAGE IS LOCATED IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924228 ↗
• MalfunctionApr 4, 2026Complete Blockage; Infusion or Flow Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INSULIN FLOW BLOCKED ALARM DUE TO OCCLUSION EVENT ON (B)(6) 2026, WHERE INSULIN DOES NOT EXIT THE TUBING WITH PLUNGER PUSH. THE BLOCKAGE WAS LOCATED IN THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784971 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE AT SITE ON (B)(6) 2024. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY ONE DAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714661 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023 DUE TO THE ADMINISTRATION OF A LARGE BOLUS (6-10 UNITS). THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714004 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE ISSUES ON (B)(6) 2024. THE PATIENT REPORTED INFUSION SET LEAKAGE AT SITE WITH TWO INFUSION SETS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713799 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE ISSUES ON (B)(6) 2024. THE PATIENT REPORTED INFUSION SET LEAKAGE AT SITE WITH TWO INFUSION SETS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713755 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION] SET LEAKAGE EVENT ON (B)(6) 2024. THE PATIENT STATED THAT THE LEAK OCCURRED AT THE INFUSION SET SITE AND THAT THE INFUSION SET HAD BEEN IN USE SINCE (B)(6) 2024. THE PATIENT WAS ABLE TO CHANGE THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713300 ↗
• MalfunctionMar 30, 2026Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2024. THE PATIENT STATED THAT THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS WHEN THE LEAK OCCURRED AT THE SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713044 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE AT SITE EVENT ON (B)(6) 2023. THE INFUSION SET WERE IN USE FOR THREE DAYS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24712294 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE INFUSION SITE ON (B)(6) 2023. THE INFUSION SET WAS IN USE FOR THREE DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701519 ↗
• MalfunctionMar 26, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THE INFUSION SET DETACHMENT EVENT ON (B)(6) 2023. THE SITE OF DETACHMENT WAS AT SITE CONNECTOR. THE INFUSION SET WAS IN USE FOR LESS THAN 16 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701374 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE AT THE SITE ON (B)(6) 2023. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701343 ↗
• MalfunctionMar 26, 2026Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE AT SITE ON (B)(6) 2024. THE SET HAD BEEN IN USE FOR ONE DAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701268 ↗
• InjuryNov 3, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO DIABETIC KETOACIDOSIS (DKA) EVENT. BLOOD GLUCOSE LEVEL WAS 20.6 MMOL/L AT THE TIME OF THE EVENT AND GOT TREATED WITH INSULIN VIA INTRAVENOUS (IV). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 23449491 ↗
• MalfunctionJun 13, 2025Material Deformation; Material Deformation

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED AN EVENT WHERE TUBING BROKE IN 2 AT 3 INCHES FROM RESERVOIR ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22204541 ↗
• MalfunctionMay 8, 2025Packaging Problem; Packaging Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT ON (B)(6) 2025 WHERE PACKAGING WAS NOT SEALED PROPERLY, MISSHAPED OR STERILE PACKAGING WAS NOT INTACT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983412 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET TUBING DETACHMENT EVENT ON (B)(6)2025 WHILE THE PATIENT WAS DOING DAILY ACTIVITIES. ALSO, THE DETACHMENT WAS IN THE CLIP. THE SITE WAS ABDOMEN AND PUMP WAS ON TOP OF JEANS. THE INFUSION SET WAS USED FOR A COUPLE OF HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941683 ↗
• MalfunctionApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931919 ↗
• MalfunctionApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931918 ↗
• MalfunctionApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON 1-APR-2025. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931913 ↗
• MalfunctionApr 29, 2025Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON 1-APR-2025. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931910 ↗